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CTRI Number  CTRI/2024/07/070942 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 20/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Triphaladi taila in management of Hypothyroidism  
Scientific Title of Study   Efficacy of Triphaladi taila in the management of Hypothyroidism- An open labeled randomized control clinical trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Purnima Jadav 
Designation  PG Scholar 
Affiliation  Government Akhandanand ayurveda college 
Address  OPD No.4 Kayachikitsa Department Government Akhandanad Ayurveda College & Hospital Bhadra Ahmedabad Gujarat 380001 India Ahmadabad GUJARAT 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  7575808311  
Fax    
Email  jadavpurnima141998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anamika Soni 
Designation  Associate Professor 
Affiliation  Government Akhandanand ayurveda college 
Address  OPD No.4 Kayachikitsa Department Government Akhandanad Ayurveda College & Hospital Bhadra Ahmedabad Gujarat 380001 India Ahmadabad GUJARAT 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  9269533108  
Fax    
Email  ayursoni@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Anamika Soni 
Designation  Associate Professor 
Affiliation  Government Akhandanand ayurveda college 
Address  OPD No.4 Kayachikitsa Department Government Akhandanad Ayurveda College & Hospital Bhadra Ahmedabad Gujarat 380001 India Ahmadabad GUJARAT 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  9269533108  
Fax    
Email  ayursoni@yahoo.com  
 
Source of Monetary or Material Support  
Government Akhandanad Ayurveda College & Hospital Bhadra Ahmedabad Gujarat 380001 India Ahmadabad GUJARAT 380001 India 
 
Primary Sponsor  
Name  Government Akhandanand Ayurveda College Ahmedabad 
Address  OPD No.4 Kayachikitsa Department Government Akhandanad Ayurveda College & Hospital Bhadra Ahmedabad Gujarat 380001 India Ahmadabad GUJARAT 380001 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Purnima Jadav  Government akhandanand ayurveda college, Ahmedabad  OPD No.4 Kayachikitsa Department Government Akhandanad Ayurveda College & Hospital Bhadra Ahmedabad Gujarat 380001 India Ahmadabad GUJARAT 380001 India
Ahmadabad
GUJARAT 		 7575808311

jadavpurnima141998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT AKHANDANAND AYURVED COLLEGE AHMEDABAD   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: AGNIVAISHAMYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphaladi taila, Reference: Bhavaprakasha Madhyam Khanda 39/16, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Gaumutra bhavit haritaki churna , Reference: Charak chikitsa 12 shoth Chikitsa , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient who is already taking levothyroxine medicine but having high S.TSH level ,S.TSH greater than 5.5 mIU per L.
Newly diagnosed patients of Hypothyroidism with S.TSH greater than 5.5 mIU per L (Sandwich chemi luminescent immuno assay method) (uncontrolled Hypothyroidism)
S.Total T3 less than 80 ng per dL
S.Total T4 less than 5.0 µg per dL 
 
ExclusionCriteria 
Details  Patients having any other major systemic diseases like Cancer, Tuberculosis, SLE, etc.
Pregnant women or Lactating mothers.
Any other debilitating disease which may lead to fatal condition for the patient at any time.
Patient having history of peptic ulcers, bleeding ulcers, bleeding piles etc.
Patients having any drug abuse.
Patients with psychiatric illness
Patients taking other medicines for any other acute disease.
If S.TSH level is more than 100mIU/L . 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Management of Hypothyroidism.
Role of tailapan in management of Hypothyroidism.Serum total tsh will be assessed before and after trial. 		 40 days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve quality of life  7 days after completion of clinical trial 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Hypothyroidism is one of the most common and challenging disease in today’s era. Hypothyroidism is a condition in which the thyroid gland does not produce enough Thyroxine(T4) and Triiodothyronine (T3).
Thyroid hormone act as catalyst for metabolism in whole body. In Hypothyroidism, there is Agnimandya and Meda Kapha vrudhdhi. Additionally there is condition of Avrutta vata due to excessive Kapha and Meda leading to Vatavaigunya and features of Vatavruddhi like dryness, menorrhagia. So the drugs which have Ushna,Kapha medahara, Vatanulomana, Ampachna, Srotoshodhana are useful in the management of Hypothyroidism.
 
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